Recruitment and enrollment of participants in an online diabetes self-management intervention in a virtual environment

Abstract

Effective recruitment of research participants is essential for successful randomized controlled trials and remains one of the most challenging and labor-intensive aspects of conducting research. The purpose of this manuscript is to describe recruitment methods for this two-group, internet-based intervention trial and enrollment status in relation to recruitment methods, accounting for accrual rates and recruitment costs and to discuss our recruitment results and limitations informed by the Clinical Trials Transformation Initiative (CTTI) team's evidence and expert-based recommendations for recruitment. The primary study was a two-group randomized controlled trial designed to evaluate the efficacy of a virtual environment, Diabetes LIVE©, compared to a traditional website format to provide diabetes self-management education and support to adults with type 2 diabetes. Our recruitment experience was labor-intensive, multimodal, and required multiple iterations throughout the study to meet recruitment goals. To allow for more efficient and realistic budgets aligned with funding, researchers should engage stakeholders in recruitment planning and monitor and report personnel time and cost by recruitment methods. To allow for more efficient and effective recruitment into meaningful clinical trials and of interest to participants, researchers should use a participative approach during all study phases, including question development.